Devices › Ventilator, continuous, facility use
Device brand name · Ventilator continuous facility use
Carescape R860: medical device reports filed with FDA
4,968 reports name it, 2015–2026. Manufacturer given most often on reports: Datex-Ohmeda. Product code CBK.
- 4,968
- device reports naming the brand
- 0% of all MAUDE reports · about 466 a year
- 50
- reports, 12 months to August 2026
- 26 in the 12 months before
- 99.2%
- classified as malfunction
- 91.8% across the product code
- 0.2%
- classified as death, as reported
- 8 reports · not verified by FDA
FDA's MAUDE database holds 4,968 reports that name the brand "Carescape R860" (ventilator continuous facility use), received between November 2015 and August 2026; the manufacturer given most often on reports is Datex-Ohmeda. Spellings of one product vary from report to report.
50 reports arrived in the 12 months to August 2026, up 92% from 26 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (99.2%), injury (0.6%) and death (0.2%); across all ventilator, continuous, facility use reports (product code CBK) death is recorded in 1.1% and malfunction in 91.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to run on battery (60.8%), insufficient flow or under infusion (13.1%) and no display/image (6.2%). The patient problems coded most often are no patient involvement, low oxygen saturation and cardiac arrest. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 213,387 reports carrying product code CBK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Failure to run on battery | 3,021 | 60.8% | 2.6% |
| Insufficient flow or under infusion | 653 | 13.1% | 1.7% |
| No display/image | 309 | 6.2% | 5.2% |
| Mechanical problema mechanical problem | 159 | 3.2% | 7.4% |
| Therapeutic or diagnostic output failure | 152 | 3.1% | 0.4% |
| Power problem | 133 | 2.7% | 1.4% |
| Unexpected therapeutic results | 87 | 1.8% | 0.1% |
| Failure to power up | 56 | 1.1% | 2.9% |
| Battery problema problem with the battery | 45 | 0.9% | 4.5% |
| Electrical /electronic property probleman electrical or electronic problem | 41 | 0.8% | 3.8% |
| Unexpected shutdown | 38 | 0.8% | 1.1% |
| Premature discharge of battery | 26 | 0.5% | 0.2% |
| Detachment of device or device componentpart of the device came off | 25 | 0.5% | 0.1% |
| Breakthe device broke | 21 | 0.4% | 0.6% |
| No visual prompts/feedback | 18 | 0.4% | 0.1% |
| Device displays incorrect message | 14 | 0.3% | 9% |
| Device operates differently than expectedthe device behaved unexpectedly | 14 | 0.3% | 5.5% |
| Device alarm system | 10 | 0.2% | 1.8% |
| Device damaged prior to usethe device was damaged before use | 10 | 0.2% | 0.1% |
| Calibration problem | 7 | 0.1% | 0.7% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 112 | 2.3% |
| Low oxygen saturation | 23 | 0.5% |
| Cardiac arrestthe heart stopped | 8 | 0.2% |
| Hypoxialow oxygen | 6 | 0.1% |
| Deaththe patient died; cause not stated by this term | 3 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0% |
| Fungal infectiona fungal infection | 1 | 0% |
| Increased respiratory rate | 1 | 0% |
| Pulmonary emphysema | 1 | 0% |
| Respiratory distressdifficulty breathing | 1 | 0% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 1 | 0% |
| Viral infectiona viral infection | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Carescape R860 | Product code CBK | All MAUDE reports |
|---|---|---|---|
| Reports | 4,968 | 213,387 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 2 | 11 | 9 |
| Classified as injury | 0.6% | 6.8% | 36.2% |
| Classified as malfunction | 99.2% | 91.8% | 62.3% |
| Filed by the manufacturer | 100% | 95.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code CBK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Trilogy 100 | 31,022 | 2,056 | 0.9% |
| 840 Ventilator | 18,191 | 27 | 0.4% |
| Hamilton Medical Ag | 10,331 | 0 | 0.3% |
| Trilogy Evo | 8,583 | 943 | 1.1% |
| Vela Ventilator | 8,446 | 0 | 0.3% |
| Servo-I | 6,390 | 3 | 1.3% |
| Esprit Ventilator | 6,015 | 0 | 0.4% |
| Vocsn | 5,308 | 854 | 0.4% |
| Trilogy 202 | 5,217 | 74 | 0.3% |
| Carescape | 4,902 | 2,289 | 0.1% |
| 980 Ventilator | 4,651 | 117 | 0.2% |
| Trilogy O2 | 4,290 | 48 | 0.3% |
| Avea Ventilator | 3,943 | 0 | 0.5% |
| V200 Ventilator | 3,476 | 0 | 0.2% |
| Uni-Vent Model 731 | 3,305 | 0 | 0.3% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Carescape R860 reports
How many FDA reports name Carescape R860?
4,968 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.
What kinds of events are reported?
malfunction (99.2%), injury (0.6%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to run on battery (60.8%), insufficient flow or under infusion (13.1%), no display/image (6.2%), mechanical problem (3.2%) and therapeutic or diagnostic output failure (3.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Carescape R860 was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.